Cleared Traditional

MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

K936181 · Midmark Corp. · General Hospital
Nov 1994
Decision
338d
Days
Class 2
Risk

About This 510(k) Submission

K936181 is an FDA 510(k) clearance for the MIDMARK M-11 ULTRACLAVE STEAM STERILIZER, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on November 30, 1994, 338 days after receiving the submission on December 27, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K936181 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1993
Decision Date November 30, 1994
Days to Decision 338 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6880

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